Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands

Summary

Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF hospitalizations but also mortality in chronic HF patients. To confirm these retrospective analyses, a prospective, randomized, placebo-controlled trial is necessary to establish the position of digoxin in the contemporary treatment of HF. Therefore, the investigators examine whether low-level, aiming for serum concentrations 0.5-0.9ng/mL, digoxin is beneficial in HF patients with reduced or mid-range ejection fractions (LVEF \<50%).

Timeline

Start

2020-07-01

Primary completion

2025-11-13

Completion

2025-11-13

Publications

• van Veldhuisen DJ, Rienstra M, Mosterd A, Alings M, Voors AA, Damman K, van Asselt ADI, Bouvy ML, Schaap J, van der Wall EE, Crijns HJGM, Touw DJ, Hoogslag PAM, van de Swaluw JEC, Schuurman RJ, van der Sluis A, Bondarenko O, Romer TJ, Oosterhof T, Bartels GL, Koudstaal S, Dijkmans PA, Linssen GCM, Aksoy I, Dorman HGR, Schut A, Hemels MEW, Tieleman RG, Lok DJA, Westendorp ICD, Vijver MAT, Voordes GHD, de Vos AH, Maas-Soer EL, Postmus D, Lunter G, Tijssen JGP, van der Meer P. Low-dose digoxin in patients with heart failure with reduced or mildly reduced ejection fraction: a randomized controlled trial. Nat Med. 2026 May 10. doi: 10.1038/s41591-026-04406-6. Online ahead of print.
• van Veldhuisen DJ, Rienstra M, Mosterd A, Alings AM, van Asselt ADJ, Bouvy ML, Tijssen JGP, Schaap J, van der Wall EE, Voors AA, Boorsma EM, Lok DJA, Crijns HJGM, Schut A, Vijver MAT, Voordes GHD, de Vos AH, Maas-Soer EL, Smit NW, Touw DJ, Samuel M, van der Meer P; DECISION Investigators and Committees. Efficacy and safety of low-dose digoxin in patients with heart failure. Rationale and design of the DECISION trial. Eur J Heart Fail. 2024 Oct;26(10):2223-2230. doi: 10.1002/ejhf.3428. Epub 2024 Aug 30.

Drugs

Indications